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China to speed up approval process for children's drugs

(CRI Online)

08:29, February 28, 2013

China's drug safety watchdog has issued a plan to shorten the approval process for children's drugs in order to encourage their research and development, CRI Online reports.

The short supply of medicine for children is becoming critical in China. Less than 60 out of 3,500 kinds of drugs on the domestic market are specifically for children, and 90 percent of them are based on decrement doses of adult medicine.

"Pharmacists usually have to break or crush the tablets of adult specifications according to the ill child's age, weight and body surface area," said Wu Jie, a doctor in the pharmacy department of Beijing Children's Hospital. "Thus the accurate operation of pharmacists is the key factor to children's drug-using safety."

While the domestic market for children's medicine faces several problems, including a lack of incentives, shortage of children's specifications, and inadequate information about dispensing medications, the difficulty of children's clinical trials is the root cause of the lack of an adequate number of children's drugs, said Wang Lifeng, director of the drug registration department at the State Food and Drug Administration (SFDA).

"Due to the unsound security mechanism, both the potential experiment subjects and clinical institutions are unwilling to participate in the research and production of children's medicine," Wang said in an interview with China Radio International.

The state has approved 58 clinical institutions for children's medicine and called for more children's hospitals to participate to boost the children's medicine market.

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